Federal officials have approved the start of human embryonic stem cell treatment experiments on patients suffering a leading cause of vision loss.
“Dry” age-related macular degeneration (AMD) blurs vision in the center of the eye, targeting a layer of cells in the retina, perhaps afflicting 10 million or more people nationwide. The Food and Drug Administration has now approved a clinical trial of human embryonic stem cell-derived tissues to replace those retinal cells in patients, according to Advanced Cell Technology of Marlborough, Mass.
“Dry AMD is the leading cause of blindness in individuals over the age of 55,” stated ACT’s Robert Lanza, in a statement. “As the population ages, the incidence of AMD is expected to double over the next 20 years.”
In the just-approved experiments, 12 people will receive 50,000 to 2000,000 retinal pigment epithelial cells derived from human embryonic stem cells to replace those lost to AMD. The Phase I/II trial will primarily judge the safety of the cells, already tested in animal experiments.
Human embryonic stem cells are generally derived from 5 to 6-day-old human embryos, a topic of intense political, legal and scientific debate in the last decade. However, the ACT cells are derived from a single-cell extraction technology, “that does not destroy the embryo,” says Lanza, in a statement.
Over the last decade, biomedical researchers have looked to the cells, which can grow into every kind of tissue, to serve as transplant treatments for a wide range of ailments, such as macular degeneration. The FDA approval marks the third approval of a human embryonic stem cell clinical trial.